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Premium Performance in an Intermediate World SPONSORED BY AUGUST 2011 A SUPPLEMENT TO Study Finds Accommodative IOLs Provide Long-Term Stability Premium IOLs Deliver the Visual Outcomes Patients Desire How Increased Life Span Affects IOL Choice Quality of Vision Metrics Show Accommodative Lenses Outperform Multifocals

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Page 1: Premium Performance in an Intermediate

Premium Performance

in anIntermediate

World

SPONSORED BY

A U G U S T 2 0 1 1A S U P P L E M E N T T O

� Study Finds Accommodative IOLs Provide Long-Term Stability

� Premium IOLs Deliver the Visual Outcomes Patients Desire

� How Increased Life Span Affects IOL Choice

� Quality of Vision Metrics Show Accommodative Lenses Outperform Multifocals

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Editorial Staff

EDITOR-IN-CHIEF, Ophthalmology Management: Larry E. Patterson, MD

EDITORIAL MANAGER, SPECIAL PROJECTS: Angela Jackson

EDITOR, SPECIAL PROJECTS: Leslie Goldberg

CONTRIBUTING EDITOR: Erin Murphy

Design and Production

PRODUCTION DIRECTOR: Leslie Caruso

PRODUCTION MANAGER: Bill Hallman

ART DIRECTOR: Michael F. Higgins

Business Staff

GROUP PUBLISHER: Douglas A. Parry

ASSOCIATE PUBLISHER: Dan Marsh

MARKETING MANAGER: Amy Wauhop

PROMOTIONAL EVENTS MANAGER: Michelle Kieffer

CIRCULATION DIRECTOR: Deb Benward

Editorial and Production Offices

323 Norristown Road, Suite 200, Ambler, PA 19002

Phone: (215) 646-8700

Copyright 2011, Wolters Kluwer Pharma Solutions, Inc. All Rights Reserved.

The Longevity Revolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3By Jay S. Pepose, MD, PhD

The Importance of Quality of Vision. . . . . . . . . . . . . . . . . . . . . . . . . . . 8By Jason Stahl, MD

Three “Rights” of Premium IOL Satisfaction . . . . . . . . . . . . . . . . . . . 10By Jeffrey D. Horn, MD

Long-term Stability of Accommodative IOLs . . . . . . . . . . . . . . . . . . 13By D. Michael Colvard, MD, FACS

Table of Contents2

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Life expectancy in the United States has increaseddramatically.1 Individuals born in the U.S. in 1900 hada life expectancy of 47.3 years versus nearly 78 yearstoday — a 64% increase.2 Increased life expectancy anda comparatively more energetic lifestyle means that theaverage American can expect to live 20-25% of our livesin active retirement.

The first wave of baby boomers reached retirementage this year and 10,000 baby boomers will reach age 65every day for the next 19 years. The fastest growing seg-ment of the population is comprised of those over theage of 85 — with a growth rate twice that of those 65 to74 and nearly four times that of the entire population.This segment now represents 10% of those over age 65and will more than triple from over 5.7 million this yearto 19 million by 2050. This article analyzes the signifi-cance that this increase in longevity may have when selecting a presbyopia-correcting IOL.

Reduced Contrast Sensitivity and AgingContrast sensitivity is an essential component of

pattern recognition.3 Good contrast sensitivity is integralto perfoming many daily tasks and functions, such as discerning facial expression, descending stairs and pouring coffee.

Just as the performance of an athlete generally declines with advancing age, contrast sensitivity also declines with each decade oflife.3,4 This age-associated loss isthe cumulative result of advancing lenticular density,ocular scatter, progressive miosis, senescent neuralchanges, ocular aberrations andloss of the youthful offset ofpositive corneal spherical aber-ration by the aging lens.3-9

Recent studies by Hayashiand colleagues10 confirm thatcontrast sensitivity decreaseswith each decade of life, even in

pseudophakes tested at the same pupil size. This study ofcontrast sensitivity and age in patients with pseudo-phakos thereby controls for confounding age-relatedchanges in the crystalline lens that can also reduce con-trast thresholds. It further substantiates that there is anindependent reduction in the neural aspect of spatialcontrast resolution with advancing age, negatively impacting an essential component of pattern recognition.

The effect of reduced contrast sensitivity on a com-plex task, such as night driving, is further compoundedby other age-related deficiencies in visual processing. Ageis associated with reduced contrast sensitivity to low spatial frequency targets presented under rapid temporalmodulation (e.g. flicker), prolonged time for dark adap-tation, impaired motion perception and slower visualprocessing speed.3 The latter refers to older individualsrequiring more time than younger ones to detect, discriminate, recognize or identify visual targets. Slowervisual processing speed has been associated with a greaterautomobile crash risk11-13, and fall risk, and motility problems, such as transitioning from sitting to standingand requiring increased time to complete typical every-day visual tasks.3

Reduced Contrast Sensitivity and Ocular DiseaseThere are a number of ocular diseases that negatively

influence contrast sensitivity. Recent studies14,15 of

The Longevity RevolutionReviewing the impact of increasing lifespan on the choice of lifestyle-enhancing intraocular lenses.

BY JAY S. PEPOSE, MD, PHD

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Just as the performance ofan athlete generally declines with advancingage, contrast sensitivityalso declines with eachdecade of life.

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diabetic patients show a decrease in foveal contrast sensi-tivity independent of lens changes and prior to the detec-tion of structural retinal changes on OCT or fundusbiomicroscopy. Glaucoma has also been shown to decrease foveal contrast sensitivity,16 while AMD,17

myopic degeneration and epiretinal membranes (ERM)all reduce contrast.

A healthy tear film has sufficient surface tension tomask the many microscopic irregularities of the ocularsurface. Dry eye syndromes unveil these irregularities, resulting in both ocular scatter and higher-order aberrations.

Prevalence of Age-related Ocular Diseases That Reduce Contrast Sensitivity

Diabetes affects approximately one in five (18.7%)persons aged 65 or greater, many of whom are undiag-

nosed. As the U.S. population ages, the impact of diabetesand diabetic retinopathy (Figure 1) will intensify, evenmore so if there’s not a reversal of the obesity epidemic.18

Of particular import, the largest increases in diabetes areexpected among adults over 75 years, projected to affect4.4 million women and 4.2 million men by 2050. Asmentioned previously, diabetes negatively impacts con-trast sensitivity independent of lens changes prior to theonset of detectable retinal pathology on ophthalmoscopyor OCT imaging.14,15

It is estimated that AMD, which compromises contrast sensitivity, is the cause of 54.4% of overall visual

impairment among Caucasians.The Beaver Dam Eye Study19

revealed that the 15-year cumula-tive incidence of early AMD inthose over 75 years of age at base-line is 24%. The AREDS study20

found that 20.2% of individualswith early stage AMD progressedto advanced disease over a 5-yearperiod at a rate of 4.0% per year.

During a 12.7-year follow-up, 40.6% of highly myopic eyes developed progres-sion of the myopic maculopathy,including diffuse atrophy, lac-quer cracks and choroidal

neovascularization.21

The Beaver Dam study22 showed that the preva-lence of glaucoma increased with age from 0.9% inpeople 43 to 54 years of age to 4.7% in people 75 yearsof age or older.

Figure 1. OCT demonstrates diabetic macular edema. Reduced contrast sensitivity can be detected even prior to retinal changes becoming visible on OCT or ophthalmoscopy.

No matter how careful one may be in preoperative examination and testing, itis not possible to accuratelyforetell whether a cataractpatient will develop futureocular comorbidities.

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The prevalence of dry eye also increases with age, affecting 5.7% of women greater than 50 years old versus9.8% of women greater than 75 years old. The age-adjusted prevalence of dry eye in women at least 50 yearsof age was 7.8% or 3.23 million women in the UnitedStates.23

Preoperative Screening It may be possible to attempt to prescreen for macu-

lar pathology, glaucoma and dry eye prior to cataract extraction. The use of a Retinal Acuity Meter (AMA Optics) may be helpful in detecting functional deficien-cies in potential retinal acuity in cataract patients with20/200 vision or better.24 OCT scans of the retina andoptic nerve may help in the detection of maculopathies,epiretinal membranes (Figure 2) and glaucoma. For example, of 45 patients referred for cataract extractionprospectively evaluated by OCT, epiretinal membraneswere noted in 7 (15.6%). Most ERM (particularly cello-phane maculopathy) were not visible by ophthalmoscopyalone. Visual acuity in eyes with ERM was worse than incontralateral eyes without.25

Dry eye testing by determination of tear osmolarity,vital dye staining and tear break up time may detect thepresence of dry eye syndromes and its effect on visualfunction.26

Ocular Disease Following Cataract ExtractionNo matter how careful one may be in preoperative

examination and testing, it is not possible to accuratelyforetell whether a cataract patient will develop future ocular comorbidities. A prospective study27 of patients 2 years following cataract extraction shows that new

systemic disease affected 18.4% of patients and that newocular disease (other than posterior capsular opacity) affected 7.2%. Another prospective study28 following patients 2 years after uncomplicated cataract extractionindicated that a loss of 2 lines or more of pinhole visualacuity was associated with the following comorbiditiesbesides PCO: AMD, glaucoma, diabetic retinopathy,branch retinal vein occlusion, epiretinal membrane, macular hole, myopic retinopathy and optic atrophy.

It is clear that the prevalence of macular degenera-tion, myopic degeneration, epiretinal membranes, diabetic retinopathy, glaucoma and dry eye will increase with ensuing years following cataract surgery,and that some of these conditions may require additionalsurgical intervention. There are three reports in the litera-ture29-31 describing difficulty in visualizing the retina during vitreoretinal surgery and epiretinal membranepeeling in patients implanted with refractive and diffractive multifocal IOLs.

Impact of Increasing Life Span on Choice of LensesWe have established that a number of prevalent

age-related diseases reduce contrast sensitivity, thatage itself reduces neural contrast sensitivity even inpseudophakes, and that pupil size generally decreaseswith each decade of age.32 How might these factorsimpact the choice of presbyopia-correcting IOLs?

The distribution of light energy between near andfar foci (and useless foci) with apodized diffractiveIOLs such as Restor (Alcon) will vary dramaticallybased on photoptic and mesopic pupil size, shape anddynamics. For example, the performance of a Restor3.0 IOL in a patient implanted at age 59 with a pupil

Figure 2. An epiretinal membrane is demonstrated by OCT, with concomitant retinal distortion. Even gossamer thin epiretinal membranes canbe associated with reduced contrast sensitivity.

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diameter that ranges from 6 mm when night drivingand 3 mm when reading in moderate light may bequite different when that patient turns 79 and has apupil that is 2.5 mm in ambient lighting, 1.5 mm

when reading and 3.5 mm when driving at night. Theeffect of progressive “senile” miosis and changes inpupil dynamics with each decade of life must be fac-tored into the future performance of some multifocalIOLs. While aggregate data32 describes average age-related reduction in pupil size, it is difficult to antici-pate the effect of age, future medications or systemicdiseases on an individual patient’s pupil size and dynamics with any degree of certainty.

Whereas family history of ocular disease, concur-rent systemic diseases, genetic markers and habitssuch a smoking may represent assessable risk factorsfor developing some ocular co-morbidities, such asAMD, it’s not possible to know with a high degree ofcertainty whether a 68-year-old patient with no signsof AMD or epiretinal membrane may develop theseconditions over the next 10 years (i.e., the current average U.S. life expectancy). We do know that as anindependent variable, advancing age itself reducescontrast sensitivity, dark adaptation, temporal sensi-tivity, motion detection and visual processing speed.

In considering IOLs that may further reduce thiswaning contrast sensitivity, the FDA has placed thefollowing warning label on the package insert of mul-tifocal IOLs: “Some visual effects may be expected dueto the superposition of focused and unfocused multiple images. These may include some perceptionsof halos or radial lines around point sources of lightunder nighttime conditions. A reduction in contrast

sensitivity as compared to a monofocal IOL may beexperienced by some patients and may be more preva-lent in low lighting conditions. Therefore, multifocalpatients should exercise caution when driving at night

or in poor visibility conditions.”

Factoring Uncertain Risks Into the Choice of an IOL

Given the extended life expectancycurrently enjoyed in the United States,1

along with the increased prevalence ofage related ocular co-morbidities thatmay further reduce contrast sensitivity,how should these factor in when choos-ing between multifocal IOLs that furtherreduce contrast sensitivity33,34 as com-pared to an accommodating IOL (e.g.Crystalens AO), which does not?

Different presbyopia-correcting IOLshave exploited varying strategies to enhance

depth of focus. These are associated with different compromises with regard to near and interme-diate visual acuity, halos, optical scatter and other aspectsof visual quality.35 Each IOL has inherent strengths andweaknesses and possesses iterative improvements incomparison to their predecessors. When choosing a spe-cific presbyopia-correcting IOL, the surgeon must assessthe patient’s current condition and also try to predict future comorbidities in deciding whether to implant anIOL that may reduce contrast sensitivity in exchange forgreater depth of focus. As an accommodating IOL, Crystalens AO does not split light between multiple focior reduce contrast sensitivity as compared to a multifo-cal IOL. As far as concerns about the potential impact ofchanges in the capsular bag with age on the mechanismof action of Crystalens, long-term studies by Drs. Doaneand Colvard of the performance of Crystalens at 3 and 7 years post-implantation show no diminution of effectat intermediate or near vision.

We are enjoying the benefits of the “LongevityRevolution.” In weighing the risks and benefits ofmultifocal versus accommodating IOL options, weneed to consider the effect of our patient’s increasedlife span along with the increasing risk of developingocular comorbidities that may both conspire to reduce contrast sensitivity.

Dr. Pepose is Director of Pepose Vision Institute and Professor of Clinical

Ophthalmology, at the Washington University School of Medicine, St. Louis, Mo. He is

a consultant to Bausch + Lomb.

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As an accommodatingIOL, Crystalens AOdoes not split light between multiple focior reduce contrast sensitivity as compared to a multifocal IOL.

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